Port Access Needle SHW20-100YSRecalls & reported problems
Bard Access Systems, Inc. · EZ Huber 20ga x 1in · Class 2
All models of Port Access Needle (122)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741089800), received between Jul 10, 2020 and Nov 20, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Activation Problem1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2020Fluid/Blood Leak
IT WAS REPORTED WHILE TRAILING HUBER NEEDLES, THE CLINICIANS HAD A FEW LEAKS AT THE Y-SITE HUB AS THEY ARE FLUSHING AT THE END CONNECTION. THE BLUE CENTER OF THE HUB POPS OUT A LITTLE AND IT LEAKS. THE FACILITY SAID THEY ARE UNSURE IF IT IS DUE TO PRESSURE OR ANOTHER FACTOR BUT STATED THEIR CONCERN FOR PATIENT AND STAFF SAFETY IF IT WERE TO HAPPEN WITH CHEMO INSTEAD OF JUST SALINE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10880573 ↗MalfunctionJul 10, 2020Activation Problem; Activation Problem
IT WAS REPORTED THE NEEDLE WAS DEACCESED FROM THE PATIENT, CLINICIAN HEARD THE CLICK, LIGHTLY PUSHED UP ON THE SHEATH AND WAS STUCK WITH THE NEEDLE. THE PATIENT IS HIV POSITIVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10260621 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page